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FDA Warns Zofran Could Cause Heart Risk

Ruben Tyler Kendrick4 years ago

The U.S. Food and Drug Administration (FDA) is warning Zofran (ondansetron) users that a single 32 mg intravenous dose of the nausea drug could cause a life-threatening heart arrhythmia.

Zofran, manufactured by GlaxoSmithKline, is used to treat chemotherapy induced nausea and postoperative nausea. The FDA has been looking into the drug’s heart-related side-effects since 2011.

32 Mg Dose Removed from Zofran Label

As reported by MedPage Today, patients who take the single 32 mg dose of Zofran could be at risk for Torsades de pointes, a life-threatening arrhythmia. Subsequently, the 32 mg dose is being removed from the Zofran label.

The new label on the drug will recommend doses of 0.15 mg/kg every four hours for up to three doses but that no dose should be greater than 16 mg. There are no changes currently being made for the oral dosing which allows up to 24 mg per dose.

Important Information for Zofran Users

  • Users should not stop taking Zofran without talking to a healthcare professional.
  • If you experience irregular heartbeat, shortness of breath, dizziness, or fainting contact a healthcare professional immediately.
  • Report any side effects to the FDA MedWatch program and contact a healthcare professional for any other questions or concerns.
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